Clinical Evaluation of Chyawanprash for the prevention of COVID-19 among Health Care Personnel .

Phase 2

• Registration Number: CTRI/2020/09/027974
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All healthcare professionals and staff of age group between 25 to 60 years willing to participate, negative for SARS- Cov-2 at screening,(tested by rt-PCR), at KGMU , without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases.

Who are willing to provide signed informed consent.

High Risk Group- It includes doctors, nursing staff and other paramedical staff like attendant who are directly looking after and examining COVID patients.

Low risk- other faculty members who are present in the institute but not visiting corona ward.

Exclusion Criteria

Pregnant and lactating females.

Immune compromised and co morbid condition cases.

Laboratory confirmed COVID-19 with or without symptoms

Known allergy to any of the medications used in this trial.

Not willing to participate in the study.

Subjects who are taking any other medicine as prophylaxis such as HCQ.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab / Chemiluminiscence assay after 1 month of consuming Chyawanprash.Timepoint: Baseline, 7th day,15th day,and 30th day

Secondary Outcome Measures

Name	Time	Method
Safety profile of the intervention as estimated by LFT, KFT and other haematological & biochemical investigations. <br/ ><br>Presence or absence of AE/ADR. <br/ ><br>Number of participants who developed any infective diseases during the trial period (bacterial /viral/ fungal / etc.) and percentage of participants with Upper respiratory tract illness during the period. <br/ ><br>Immune and inflammatory markers (IgG, IgM, IgE, Hs-CRP TNF - α,IL6, IL10) baseline and end of treatment. <br/ ><br>Timepoint: Baseline ,on 7th day,on 15th day,and completion of study 30th day.